Abstract: The present disclosure is directed to a bioreactor or fermenter for the culturing of cells or microorganisms in suspension in a liquid medium in industrial scale comprising a vessel containing the culture in a liquid medium having a determined filling height; a stirrer provided in the vessel to stir the liquid medium; a first sparger arranged in the bottom portion of the vessel; and a second or optional more spargers provided above the first sparger to supply additional air bubbles and/or additional oxygen gas bubbles continuously to the liquid medium whereby the second sparger is located at a position in the bioreactor or fermenter above the first sparger in a predefined distance ?. It is also described a process for the independent management of dissolved CO2 and O2, by selecting a suitable modified gas flow rate qmod.

Abstract: The present invention relates to a method for producing the anti-IL36R antibody spesolimab. More specifically, the present invention relates to a method of producing spesolimab with a serum-free cell culture medium in a fed-batch culture in the presence of reduced copper and increased iron concentrations. In addition, the present invention relates to a composition comprising low levels of basic species of spesolimab and/or low levels of spesolimab species with high mannose structures.